The Ultrasonographic Changes of Intercostal Muscles and Diaphragm in Mechanically Ventilated Preterm Neonates

NCT ID: NCT05495763

Last Updated: 2022-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-31

Study Completion Date

2023-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Invasive mechanical ventilation induces ventilator induced diaphragmatic dysfunction particularly when used for long time and Intercostal muscles as well contribute to the important work of respiratory movement by expanding the thorax , and determining the thickness of them would be a useful parameter in evaluating respiratory muscle activity.

This study will add the impact of mechanical ventilation on the diaphragm and intercostal muscles in preterm infants using ultrasound.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mechanical Ventilation Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Preterm infants from 28-36 weeks gestation
2. In need for invasive mechanical ventilation according to work of breathing, oxygen saturation and blood gases .

Exclusion Criteria

* 1\) Significant congenital anomalies including cardiac, abdominal or respiratory.

2\) Congenital anomalies involving the diaphragm. 3) Phrenic nerve paralysis. 4) Congenital muscular dystrophies. 5) Major upper or lower airway anomalies. 6) Storage diseases.
Minimum Eligible Age

5 Minutes

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Noha Saied Ibrahim

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Noha Saied Ibrahim

Resident at Pediatrics hospital ainshams university

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Noha Ibrahim, MB, BCh

Role: CONTACT

01064099564

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aya M Shebana, MD

Role: primary

01222273323

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Noha ibrahim

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Non-invasive Ventilation in Preterm Infants
NCT05987800 ACTIVE_NOT_RECRUITING NA